Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 20, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (each gram contains)

    Bacitracin zinc 400 units

    Neomycin sulfate 5 mg
    (equivalent to 3.5 mg of neomycin base)

    Polymyxin B sulfate 5000 units

  • Purpose

    First Aid Antibiotic

  • Uses

    first aid to help prevent infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use:

    • in the eyes or apply over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • the condition worsens
    • a rash or other allergic reaction develops

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • Other Information

    • store at 15°-25°C (59°-77°F)
    • tamper evident sealed packets
    • do not use packet if opened or torn
  • Inactive ingredients

    petrolatum

  • Questions?

    888.900.2920

    prostatfa.com

  • PRINCIPAL DISPLAY PANEL – ProStat 25 count box

    PROSTAT
    FIRST AID

    Part No. #2009

    Triple Antibiotic
    Bacitracin, Neomycin, Polymyxin

    Ungüento Triple Antibiotico
    Bacitracina, neomicina, polimixina

    25 pcs Unit Dose • 0.5g - (1/55 oz) each

    PRINCIPAL DISPLAY PANEL – ProStat 25 count box
  • PRINCIPAL DISPLAY PANEL – Front Line 25 count box

    FRONT LINE

    Triple Antibiotic
    Bacitracin, Neomycin, Polymyxin

    Ungüento Triple Antibiotico
    Bacitracina, neomicina, polimixina

    25 pcs Unit Dose • 0.5g - (1/55 oz) each

    PRINCIPAL DISPLAY PANEL – Front Line 25 count box
  • PRINCIPAL DISPLAY PANEL – packet

    PROSTAT
    FIRST AID

    Triple Antibiotic

    0.5 g (1/57oz)

    Distributed by:
    ProStat First Aid LLC,
    Valencia, CA 91355

    PRINCIPAL DISPLAY PANEL – packet
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-5600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin400 [USP'U]  in 1 g
    neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) neomycin3.5 mg  in 1 g
    polymyxin b sulfate (UNII: 19371312D4) (polymyxin b - UNII:J2VZ07J96K) polymyxin b5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-5600-125 in 1 BOX09/20/2013
    1NDC:58228-5600-00.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:58228-5600-225 in 1 BOX09/20/2013
    2NDC:58228-5600-00.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/20/2013
    Labeler - ProStat First Aid (061263699)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(58228-5600)
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